Kornimate/medical-research-clean huggingface dataset:
gemcitabine or gemcitabine and cisplatin in the treatment of advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to evaluate the impact of the addition of cisplatin to gemcitabine in the treatment of patients with inoperable advanced pancreatic cancer.


Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis pancreatic cancer * inoperable stage ii or stage iii or iv disease(uicc, 1997) * age 18 to 75 years * karnofsky performance status \> 50 * signed informed consent exclusion criteria: * previous chemotherapy * cerebral metastases * previous malignancies in past 5 years excluding adequately treated basal or spinocellular skin cancers and insitu cervical cancer * leukocytes \< 4000 or neutrophils \< 2000 or platelets \< 100000 or hemoglobin \< 10 g/dl * creatinine value \> upper normal limit * got or gpt \> 2.5 times upper normal limit or bilirubin \> 1.5 times upper normal limit in absence of hepatic metastases * congestive heart failure, severe cardiac arrhythmias or coronary ischemic disease * other concurrent disease that would, in the investigator's opinion, contraindicate the use of the study drugs * inability to provide informed consent * inability to comply with follow-up.

Keywords: chemotherapy advanced cancer inoperable stage ii, iii, iv
elucidate vasodilatory capacity from histology-defined analysis of coronary ct angiography

Conditions: Vascular Diseases

Summary: coronary ct angiography (ccta) may be an ideal modality to fill gaps in understanding the extent and rate of progression coronary artery disease. the investigators have developed an image analysis software elucidvivo that estimates relevant indices, including fractional flow reserve (ffr) . in this study, the investigators aim to assess the value of elucidvivo-based plaque morphology characterization for predicting non-invasive ffr in patients with suspected coronary artery disease (cad) who had undergone clinically indicated coronary cta and invasive coronary angiography (ica) for physical ffr measurement.

invasive ffr is a clinically validated measure of lesion-specific ischemia and is preferred over visual estimation of diameter stenosis for clinical decisions regarding coronary revascularization. ffr derived from coronary cta (ffrct) using computational fluid dynamics (cfd)-based software has been shown to be a reasonably accurate estimate of invasive ffr and is included in contemporary guidelines as a decision-tool for management of patients with intermediate stenosis on coronary cta. however, other methods have limitations. it is understood that the burden and type of coronary atherosclerosis, in addition to lumen stenosis, significantly impacts the vasodilatory capacity of the vessel walls which may provide a more interpretable analysis and broader clinical acceptance.

Eligibility criteria:
inclusion criteria: * subject must have successfully completed at least one (possibly multiple) ccta for known or suspected coronary artery disease. * ccta was no more than 60 days earlier (and not later) exclusion criteria: * subject has a history of percutaneous coronary intervention (pci) with stent implantation and/or coronary artery bypass grafting (cabg) * subject with insufficient ccta image quality (defined strictly as documented in the elucidvivo reading manual)
minimally invasive treatment of worn dentition with innovative cad-cam composites

Conditions: Tooth Wear

Summary: this study evaluates the effectiveness of a minimally invasive treatment, consisting of partial polymer-infiltrated-ceramic-network (picn) restorations, used in case of rehabilitation of advanced and generalized dental wear over a period of 5 years.


Eligibility criteria:
inclusion criteria: * patients presenting advanced and generalized worn dentition * all the posterior teeth (minus 2) present wear * all the anterior teeth (tooth n°13 to n°23) need palatal veneers exclusion criteria: * more than one missing tooth on each mandible * patients with crown(s), bridge(s) or implant(s) * patients with non-stabilized parodontite * smoker * patients suffering from : 1. parkinson's disease 2. severe osteoarthritis 3. spontaneous pain in the temporomandibular joints, shift of the mandible and an opening limit (25 mm) * conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability

Keywords: cad-cam composites worn dentition minimally invasive treatment
oslo balloon angioplasty versus conservative treatment

Conditions: Peripheral Vascular Disease

Summary: background: percutaneous transluminal angioplasty (pta) has been popularized as a simple, effective and cheap treatment achieving 50-70% symptomatic patency rates in patients with peripheral occlusive disease.. however, the fact remains that the indication for performing pta are still more based on opinions than on scientific data. the purpose of the trial was to randomize patients primarily referred for intermittent claudication into two groups: one group was offered conservative treatment; the other group was offered conservative treatment combined with pta. primary outcome: the patient quality of life. secondary outcome:pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers


Eligibility criteria:
inclusion criteria: * age below 75 years * symptoms of intermittent claudication with duration \> 3 months * abpi \<0.9 * a two-year follow-up is possible exclusion criteria: * subjective pain-free walking distance \> 400m * critical ischemia * previous vascular or endovascular surgery * diabetes ulcer * other physical disability abrogating organised exercise * use of warfarin * mentally unable to give informed consent * renal insufficiency * coagulation disorders duplex or pta impossible

Keywords: atherosclerosis quality of life pain-score biomarkers
reliability of dosing with novolog® mix 70/30 flexpen® compared with vial and syringe

Conditions: Diabetes; Diabetes Mellitus, Type 2; Delivery Systems

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to compare desired (target) with actual target amounts of insulin dispensed using novolog® mix 70/30 flexpen® and vial and syringe in subjects with type 2 diabetes mellitus. no insulin is administered in this trial - insulin is dispensed into an empty vial.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * insulin naive * no previous experience administering injections exclusion criteria: * any condition that, in the investigator and/or sponsor's opinion, could interfere with the results of this trial
impact of myofascial release on dysphagia in parkinson's disease patients

Conditions: Parkinson Disease

Summary: the goal of this clinical trial is to explore clinical effect of myofascial release therapy in dysphagic parkinson's patients. the main question it aims to answer is: • can myofascial release therapy improve swallowing function in parkinson's patients? patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given myofascial release therapy. the study lasts 21 days for each patient. researchers will compare the functional oral intake scale, penetration-aspiration scale, swallowing quality of life to see if the myofascial release therapy can help improve the situation.

myofascial release, also known as fascial release or fascial manipulation, is a physical therapy used to treat muscle and fascial tissue tension or pain. it involves applying appropriate pressure and stretching to release tight fascia and soft tissues, improving blood circulation, alleviating pain, and promoting rehabilitation. the goal of this clinical trial is to explore clinical effect of myofascial release therapy in dysphagic parkinson's patients. the main question it aims to answer is: • can myofascial release therapy improve swallowing function in parkinson's patients? patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given myofascial release therapy. the study lasts 21 days for each patient. researchers will compare the functional oral intake scale, penetration-aspiration scale, swallowing quality of life to see if the myofascial release therapy can help improve the situation.

Eligibility criteria:
inclusion criteria: * age \>18 years. * meeting the diagnostic criteria for parkinson's disease. * diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study. * water swallow test\> level 3. * stable vital signs, conscious, able to cooperate with assessment and treatment. exclusion criteria: * dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases. * complicated with cognitive impairment or consciousness dysfunction. * simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases. * complicated with severe liver and kidney failure, tumors, or hematological disorders.
septic encephalopathy and late cognitive dysfunction

Conditions: Sepsis; Severe Sepsis

Summary: delirium and long-term cognitive dysfunction are important problems in intensive care patients. patients with sepsis are at a high risk of developing delirium (septic encephalopathy), which may be an important risk factor for the development of long-term cognitive dysfunction. working hypotheses: 1. septic encephalopathy and cognitive dysfunction are caused by an unspecific reaction of the brain to an intense inflammatory stimulus. 2. it is possible to therapeutically influence the inflammatory response and its effects on the brain.


Eligibility criteria:
inclusion criteria: * admitted to an intensive care unit for treatment of sepsis, severe sepsis or septic shock * age 18 or older exclusion criteria: * primary infection of the cns * history of cerebrovascular disease * history of any neoplasia involving the cns * history of long-term psychiatric medication * history of allergy to fish- or egg-protein * severe coagulation abnormalities * clinical signs of altered coagulation, active bleeding * pregnancy
cardiac mri for detection of acute and chronic cardiac involvement in patients with epilepsy

Conditions: Epilepsy; Cardiomyopathies

Summary: the aim of the study is to use multiparametric cardiac mri to identify any abnormalities in myocardial structure and function in patients with epilepsy. a two-stage study design is planned as part of the study: 1. in the acute setting, cardiac mri will be performed in patients before and after a tonic-clonic seizure and compared intraindividually. in this study arm, potential acute seizure-induced myocardial damage will be detected. 2. in the chronic setting, cardiac mri will be performed in patients with known chronic epilepsy during the seizure-free interval to detect potential chronic myocardial damage (myocardial fibrosis) and compared with a control population. within the group of epilepsy patients, possible associations with various epilepsy-specific characteristics (e.g., form, cause, onset, duration, and severity of epilepsy) will be investigated.


Eligibility criteria:
inclusion criteria: 1. diagnosed epilepsy 2. examination under usual antiepileptic pharmacotherapy or medication up-dosing (if medication was reduced during video-eeg recording) 3. age between 18-60 years exclusion criteria: 1. underlying cardiac disease, e.g. coronary artery disease, previous myocardial infarction, previous myocarditis, complex congenital heart defect, known cardiomyopathy of other cause 2. pregnant and breastfeeding women 3. patients who use iud for contraception 4. patients with a contraindication to contrast enhanced mri
study to develop a screening tool for functional capacity in anemic subjects with nonmyeloid malignancies receiving chemotherapy and darbepoetin alfa

Conditions: Anemia; Non-Myeloid Malignancies

Summary: the purpose of this study is to develop a functional capacity screening tool (fcst) that estimates at baseline the functional capacity of anemic subjects with nonmyeloid malignancies receiving multicycle chemotherapy. sites will be randomly assigned in 1:1 ratio to 1 of 2 different subject-reported functional capacity questionnaires. the questionnaires will be used to develop the fcst. subjects will participate in the modified harvard step test (mhst) at required timepoints and receive darbepoetin alfa once every 2 weeks for 15 weeks. all subjects will return for a follow-up visit 2 weeks after the last dose of darbepoetin alfa.


Eligibility criteria:
inclusion criteria: * non-myeloid malignancies * anemia (hgb less than or equal to 11.0 g/dl) related to cancer and chemotherapy * plan to receive cyclic chemotherapy for an additional 8 weeks * eastern cooperative oncology group (ecog) performance status of 0 to 1 * adequate renal and liver function * ability to participate in the mhst based on clinical judgement of investigator * at least 18 years of age exclusion criteria: * iron deficiency * received recombinant human erythropoietin (rhuepo) therapy within 4 weeks prior to enrollment * unstable cardiac disease * current active condition creating clinical danger for the subject to participate in the mhst * known positive test for hiv infection * previous hematologic disorder associated with anemia * currently receiving beta-blockers * use of drugs or devices not approved by the fda for any indication * pregnant or breast feeding * known hypersensitivity to any recombinant mammalian-derived product

Keywords: anemia non-myeloid malignancies darbepoetin alfa chemotherapy
virtually augmented self hypnosis in peripheral vascular interventions

Conditions: Anxiety Postoperative; Pain, Postoperative; Vascular Access Site Pain

Summary: the aim of our study is to compare patients anxiety and pain during percutaneous vascular interventions with and without virtual reality autohypnosis.

the participants in the control group will be treated under local anesthesia, following the usual care protocols. the participants in the experimental group will be treated under the same conditions, except that they will experience virtual reality autohypnosis during the intervention.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * \> 18 years * any indication for a percutaneous vascular interventional with a single vascular access (angiography, phlebography, arterial intervention, venous intervention) planned to be done under local anesthesia exclusion criteria: * no french language comprehension, deaf or visually impaired patient * inability to sign informed consent * need of sedative medication * history of motion sickness * history of psychiatric disease such as paranoia, schizophrenia, deep water phobia and dementia * patient does not tolerate the virtual reality mask during the pre operative visit at day 1

Keywords: anxiety pain virtual reality virtual reality autohypnosis hypnosis non-pharmacological approaches
quitting caffeine for better glucose metabolism

Conditions: Diabetes Mellitus, Type 2

Summary: this project is a pilot study of caffeine abstinence in coffee-drinkers who have type 2 diabetes. evidence suggests that caffeine may impair the control of glucose levels, especially in those people who have type 2 diabetes. eliminating caffeinated beverages from the diet might improve glucose control, but the difficulty of quitting is unknown. this pilot study will follow a small number of type 2 diabetic patients for three months after a brief intervention designed to help people quit caffeine. data on success with maintaining abstinence and on changes in glucose control will be collected.


Eligibility criteria:
inclusion criteria: * 6-month history of type 2 diabetes * impaired chronic glucose control (hba1c \>= 7%) * daily consumption of 250 mg caffeine or more in coffee, tea, and other caffeinated beverages exclusion criteria: * use of exogenous insulin * use of non-diabetes medications that impact glucose metabolism * medical of psychiatric history that prevents participation or increases risk * current pregnancy * current participation in other clinical trials * deemed unable to comply with the study protocol for other reasons
collision warning device for blind and visually impaired

Conditions: Hemianopia; Hemianopsia; Peripheral Visual Field Defect; Blindness; Retinitis Pigmentosa; Glaucoma

Summary: this study evaluates a novel collision warning device to help people with severe vision impairment or blindness avoid collisions with obstacles. the main hypothesis to be tested is that the device reduces the number of collisions with obstacles in everyday activities.

participants with blindness or severe visual field loss (hemianopia or tunnel vision) will be trained to use a collision warning device that alerts them to impending collisions. participants will use the device at home during everyday mobility for about 1 month. the device is designed to supplement existing mobility devices, such as a long cane or dog guide. the device will provide warnings about potential collisions with mid- or high-level obstacles (which are typically not detected by a long cane).

Eligibility criteria:
inclusion criteria: * blindness (or very limited vision with visual acuity no better than "counting fingers"), * or severe peripheral field loss / tunnel vision (≤ 40° remaining visual field) with visual acuity of at least 20/200, * or homonymous hemianopia with visual acuity of at least 20/200; * able to walk independently either with or without mobility aids such as a long cane or guide dog (but without the aid of a sighted guide); * reports at least minor bumps or collisions within the last 3 months; exclusion criteria: * currently participating in a mobility training program * diagnosed dementia * significant cognitive decline * participants with hemianopia will be excluded if they have hemianopia for less than 3 months and/or have spatial neglect
short term outcomes of fracture odontoid management

Conditions: Spine Injury

Summary: the aim of this study is to evaluate and assess the short-term outcomes of odontoid fracture cases admitted to trauma unit of assiut university hospital.

patients with completed records, cts, and plain radiographs. sufficient clinical records with documented ndi, the patient will be evaluated in 2 weeks, 6 weeks , and 3 , 6 months post operative .

Eligibility criteria:
inclusion criteria: * all patients with odontoid fractures admitted to assiut university hospital - department of orthopedics and trauma between october 2021 and june 2023 exclusion criteria: * patients who are not available for 6 months follow-up and those with insufficient documentation or records

Keywords: odontoid fracture, upper cervical fracture, anterior odontoid screw, ndi.
sleep, awake & move - part i

Conditions: Idiopathic Parkinson Disease

Summary: sleep benefit (sb) is a prominent spontaneous, apparently unpredictable, transitory improvement in motor function reported by around 50% of patients affected by parkinson's disease (pd) after sleep and before taking their first dose of dopaminergic medications. this study aims at systematically characterizing sb in pd patients in an ecological setting and to explore the relationships between nocturnal and diurnal sleep and subjective and objective measures of motor function. a better understanding of this phenomenon is mandatory for future research on this topic.

the "sleep \& move" study is the first part of the sleep, awake \& move project. in this observational study we plan to systematically investigate sb and the day-to-day variation in this phenomenon in pd patients by a prospective, repeated assessment for 14 days of both subjective and objective measures of motor function and sleep at patients' home, by an android app developed ad hoc by our group and named "sleepfit". since is still unknown if a spontaneous, subclinical improvement in motor performance might also occur in healthy subjects or if the sb is a phenomenon only involving subjects with pd, we had the idea to test this hypothesis comparing a subgroup of pd patients with age- and sex-matched healthy volunteers, employing the same assessments as in the sleep \& move study.

Eligibility criteria:
parkinson's disease group: inclusion criteria: * diagnostic criteria of idiopathic parkinson's disease (ukpdbb) * mild to moderate disease (hoehn \& yahr score ≥ 1 and \<= 3) * mentally and physically capable to give informed consent * stable antiparkinsonian and psychotropic therapy for the last 30 days healthy group: inclusion criteria: * absence of parkinson's disease * mentally and physically capable to give informed consent all subjects: exclusion criteria: * atypical parkinsonian syndrome * cognitive impairment (mmse ≥ 26) * history of cerebro-vascular disease, epilepsy, or other disabling neurological diseases * psychiatric disorders, excepting mild depression (bdi score \<14) * alcohol abuse * other clinically significant severe concomitant disease states * inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, etc.) * participation in another study with investigational drug within the 60 days preceding and during the present project.

Keywords: parkinson's disease sleep benefit
a post-marketing study for on label evaluation of the ge vscan ultrasound imaging system

Conditions: Left Ventricular Dysfunction; Right Ventricular Dysfunction; Pulmonary Hypertension; Heart Valve Diseases

Summary: this study is to collect data and learn more about the vscan ultrasound imaging system. it is an "observational" study with no additional procedures or intervention prescribed other than using the vscan along with a routine medical physical exam.

the study requires 2 visits to ohsu. at the first visit a cardiac physical exam will be done by a cardiologist. at a second visit, a different cardiologist will perform an ultrasound scan (as part of your standard of care) using a vscan ultrasound system. the first and the second visit may be done on the same day depending upon your schedule and if it's convenient for you to stay. the total exam time for both the visits, including standard exam and the study device exam will be about 45 minutes.

Eligibility criteria:
inclusion criteria: * 18 years or older * provided signed and dated informed consent and is willing to provide ge healthcare with demographic data, cardiac medical history, information collected as part of the study * new patients who have an echocardiogram less than 6 months and patients who will be undergoing an echocardiogram as part of their routine clinical care exclusion criteria: * pregnant * less than 18 years of age. * unwilling to provide informed consent